Clinical Trials Logo
  1. Home
  2. Rheumatoid Arthritis
  3. NCT00641225
  4. Details
NCT00641225 Clinical Trial

Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00641225
Other study ID # 3227K1-1000
Secondary ID B2261001
Status Completed
Phase Phase 1
First received
Last updated
Start date March 31, 2008
Est. completion date March 31, 2011

Study information
Verified date September 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and tolerability of single doses of SBI-087 in subjects with rheumatoid arthritis.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date March 31, 2011
Est. primary completion date March 31, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit. - Must meet criteria for rheumatoid arthritis with functional class I to III. - Diagnosis of rheumatoid arthritis more than 6 months before study day 1 and rheumatoid arthritis onset after 16 years of age Exclusion Criteria: - Any significant health problems other than rheumatoid arthritis. - Treatment of greater than 10 mg of prednisone per day. - Treatment with cyclophosphamide.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SBI-087
Single IV doses of SBI-087 from 0.015 mg/kg to 2 mg/kg and Single SC doses of SBI-087 from 50 mg to 300 mg.

Locations
Country Name City State
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Toronto Ontario
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Miami Florida

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Emergent Product Development Seattle LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis. 12 months
Secondary To provide the initial pharmacokinetics and pharmacodynamic profile of SBI-087 in subjects with rheumatoid arthritis. 12 months
See also
  Status Clinical Trial Phase
Completed NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Completed NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT06005220 - SBD121, a Synbiotic Medical Food for RA Management N/A
Recruiting NCT05451615 - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis Phase 3
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05496855 - Remote Care in People With Rheumatoid Arthritis N/A
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06031415 - Study of GS-0272 in Participants With Rheumatoid Arthritis Phase 1
Recruiting NCT06103773 - A Study of Single and Multiple Oral Doses of TollB-001 Phase 1
Completed NCT05999266 - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting NCT05302934 - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4

External Links